This blog discusses the development of pharmacokinetic CDISC data standards and the impact of building them for electronic regulatory submissions.
Data heterogeneity is a regulatory reviewer’s nightmare. Some sponsors talk about patient “gender” whereas others list the patient’s “sex.” What about date formats? Do you use the American-style month-day-year format or the European-style day-month-year? Inconsistent data presentation makes both collaborating on drug development projects and reviewing regulatory submissions more difficult. To address this challenge, the … Continued
In December 2014, the US FDA published a binding guidance document, Guidance for Industry – Providing Regulatory Submissions in Electronic Format – Standardized Study Data, that establishes a requirement for submitting study data (clinical and non-clinical) in electronic format conforming to CDISC standards. The study data requirement is not retroactive and will only apply to … Continued
A recent report by Deloitte identified the #1 trend in the life sciences market as an increased focus on patient safety and enforcement. While it seems obvious to consider safety issues in approved drugs, regulatory agencies such as the FDA and EMA (European Medicines Agency) are extending their scrutiny to the entire drug development process, … Continued